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RECRUITING
NCT07214311
PHASE2/PHASE3

Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty

Sponsor: Peptilogics

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement, Antibiotics, and Implant Retention) surgical procedure to treat a Prosthetic Joint Infection (PJI). The study will also assess the safety of PLG0206 when used as an irrigation solution during the DAIR procedure. Participants will receive either PLG0206 or a placebo (an inactive substance that looks like the investigational drug), in addition to standard of care treatments. All participants will be monitored for approximately one year following their DAIR procedure.

Official title: RETAIN: A Phase 2/3 Randomized, Placebo-Controlled Study to Evaluate the Efficacy of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Total Knee Arthroplasty (TKA)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-02-03

Completion Date

2028-09

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

PLG0206

PLG0206 Solution

DRUG

Placebo

Placebo

Locations (8)

Clinical Trial Site

Sarasota, Florida, United States

Clinical Trial Site

Tamarac, Florida, United States

Clinical Trial Site

Baltimore, Maryland, United States

Clinical Trial Site

Boston, Massachusetts, United States

Clinical Trial Site

Cincinnati, Ohio, United States

Clinical Trial Site

Columbus, Ohio, United States

Clinical Trial Site

Pittsburgh, Pennsylvania, United States

Clinical Trial Site

Morgantown, West Virginia, United States